Internet-based disease monitoring system

ABSTRACT

An Internet-based disease monitoring system may include a network-based disease sensor device, which is coupled to a sensor, such as a spirometer. A remote server may be coupled to the network-based disease sensor device to provide analysis of input signals from the sensor. The remote server may be able to provide various services for grouping or handling functions relating to such input signals. A service may provide the ability to aggregate input signals from multiple sensors coupled to sensor devices and provide predictive modeling or statistical analysis, which may then be used to adjust future input signals. A service may also contain instructions how to handle billing based on usage of the network-based disease sensor device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/854,031 filed Sep. 14, 2015, which is a Continuation-In-Part of PCTApplication No. PCT/US2014/025693, filed Mar. 13, 2014, which claims thebenefit of and priority to U.S. Provisional Application No. 61/785,696filed Mar. 14, 2013, the entireties of which are hereby incorporatedherein by reference.

FIELD OF INVENTION

The present disclosure relates to effective, efficient, and economicalmonitoring of diseases in real-time by integrating patient sensors,cell-phone technology, and the Internet in telemedicine and healthcareinfrastructure. In particular, the present disclosure relates to aunique configuration of technology for automated patient-run, real-timemonitoring of diseases like asthma and chronic obstructive pulmonarydisease (“COPD”), as in spirometry, with interactive and real-timecommunication among the patient, healthcare providers, medical insurancecompanies, and others via the Internet and mobile communication devicessuch as personal computers, tablets, and smartphones. The modularconfiguration of the system allows replacing one sensor module withanother to monitor parameters for other ailments such as blood pressure,blood glucose, cholesterol, oxygen saturation, nitric oxide,electrocardiogram (“EKG”), and others.

BACKGROUND OF THE INVENTION

Improving the level of healthcare requires accurate diagnosis and morefrequent monitoring of health conditions. The rising cost of healthcaremakes it difficult for patients to achieve such higher levels ofhealthcare. As patients become more educated about their health, more ofthe high tech miniaturized electronic technologies become affordablyavailable.

Achieving higher efficiency, greater frequency of monitoring, higherperformance, real-time communication, minimized maintenance, and lowercosts as well as the reduced burden of carrying various portable deviceswill greatly enhance healthcare quality. Patients with multiple diseasesto be monitored require multiple instruments to be carried, in additionto other consumer devices like cellular phones. A lot of functionalityis redundant in the various instruments and devices. One aspect of thepresent invention aims to efficiently consolidate and utilize thecommonalities of function and redistribute it to achieve optimum cost,ease of use, and greater functionality most comprehensively. By way ofexample, this aspect of the present invention provides an Internet-baseddisease monitoring system (“IDMS”) that can be utilized for mostcritical and commonly monitored ailments and conditions. Theredistribution is aimed at allocating technical complexities and costssuch that all component, process, and system nodes are well integratedfor optimum results with the patient end being the most compact andleast costly for maximum ease and utility.

Recently there have been advancements in the field of telemedicine suchas eHealth, electronic medical record/electronic health record(“EMR/EHR”), Healthcare informatics and personal connected healthcare,enabling the use of mobile communication devices (such as smartphones)to connect existing medical devices (such as glucometers and pulseoxymeters) to Internet-based servers for uploading data to patientrecords. However, since all the computations are currently conducted onfull-function devices, any upgrades to the system require changing thedevice or physically upgrading it. There is limited ability to integratethe various nodes in the healthcare spectrum. The user is still requiredto carry each device along with the smartphone, with the inherentredundancy of the device housing, microprocessor, software, display,keypad, electronics, etc.

SUMMARY

According to one aspect of the present invention, an Internet-baseddisease monitoring system includes a patient-operated device thatincludes a sensor module and a transmitter module. The sensor producesinput signals responsive to a patient condition, and the transmitter iscoupled to the sensor and produces output signals corresponding to theinput signals produced by the sensor. A mobile communication device(such as a cell phone) is responsive to wireless receipt of the outputsignals from the patient-operated device and forwards the output signalsto a predetermined network address. A remote server at the networkaddress is responsive to the output signals received from the mobilecommunication device and analyzes the output signals. The remote serverfurther produces analysis signals representing the results of theanalysis, and transmits the analysis signals to predetermined recipientsassociated with the patient-operated device.

According to another aspect of the invention, an Internet-based methodfor monitoring disease includes producing, via a sensor of apatient-operated device, input signals responsive to a patientcondition. Output signals corresponding to the input signals aretransmitted via a transmitter of the patient-operated device. The outputsignals are further forwarded, via a mobile communication device, to apredetermined network address. The output signals are analyzed, via aremote server at the network address, and analysis signals representingthe results of the analysis are produced. The analysis signals aretransmitted, via the remote server, to predetermined recipientsassociated with the patient-operated device.

According to yet another aspect of the invention, a device is directedto determining body function parameters based upon the movement of apatient's breath. The device includes two modules, i.e., a sensor moduleand a transmission module. The sensor module includes a sensing elementand a biasing element. The transmission module includes a light source,a light receiver, a transducer, a processor, and a wireless transmissioncomponent (such as Bluetooth or ZigBee). The housing forms a flowchamber having a first port in which a human breath is accepted and asecond port from which the breath is exhausted. The flow chamber furtherhas an interior surface. The sensing element is movably mounted withinthe flow chamber and moves bi-directionally in response to pressure fromthe exhaled breath received from the patient into the first port and inresponse to pressure due to the breath inhaled by the patient throughthe flow chamber. The biasing element resists movement of the sensingelement and returns the sensing element to a home position in theabsence of any pressure from the exhaled or inhaled breath. The lightsource transmits a light beam onto the interior surface of the flowchamber. The light receiver receives light reflected off the interiorsurface. The receiver is stationary while the source of the lightdirected onto the interior surface of the flow chamber is mounted formovement with the sensing element as the sensing element is moved withinthe flow chamber. The transducer is coupled to the light receiver andconverts the reflected light into electrical signals. The processorsreceive and process the electrical signals, and determine, in responseto the pressure from the breath, the extent of the movement of thesensing element. In response to determining the extent, velocity, anddirection of the movement, the processor further determines themagnitude of the pressure.

According to yet another aspect of the invention, a device is directedto determining body function parameters based upon the movement causedby a human breath. The device includes a base, a housing, a sensingelement, a biasing element, at least one microphone, an acousticemitter, an acoustic receiver, a transducer, and a processor. Thehousing is detachably mounted to the base and forms a flow chamberhaving a first port in which a human breath is received and a secondport from which the breath is exhausted during the exhalation maneuver.The sensing element is movably mounted within the flow chamber and movesin response to pressure from the breath received in or out through theflow chamber. The biasing element resists movement of the sensingelement and returns the sensing element to a home position in theabsence of any pressure from breath received into the first port. Themicrophone detects acoustic signals generated by the human breath andthe acoustic emitter emits acoustic signals onto the sensing elementwithin the flow chamber. The acoustic receiver receives the acousticsignals reflected off the sensing element as the sensing element isdisplaced by the pressure of the breath. The transducer is coupled tothe acoustic receiver and converts the acoustic signals into electricalsignals based on the extent, velocity (rate of displacement/movement),and direction of the air flow. From this raw data, the server computesthe volume, rate of breath flow, and other calculated respiratoryfunction parameter.

BRIEF DESCRIPTION OF THE DRAWINGS

Additional aspects of the invention will be apparent to those ofordinary skill in the art in view of the detailed description of variousembodiments, which is made with reference to the drawings, a briefdescription of which is provided below.

FIG. 1 is a diagrammatic illustration of one embodiment of atelemedicine system with various software modules embodying theinvention.

FIG. 2 is a diagrammatic illustration representing the operation of atelemedicine system illustrated in FIG. 1 .

FIG. 3 is a diagrammatical illustration of a sensor and transmittermodule (“STM”) for use by a patient.

FIG. 3A is a diagrammatical illustration of a sensor and transmittermodule (“STM”) for use by a patient.

FIG. 3B is a diagrammatical illustration of a sensor and transmittermodule (“STM”) for use by a patient.

FIG. 3C is a diagrammatical illustration of a sensor and transmittermodule (“STM”) for use by a patient.

FIG. 4 is a flow chart illustrating the operation of the telemedicinesystem illustrated in FIG. 1 .

FIG. 5 is a flow chart of an application for enabling a mobilecommunication device to communicate with an STM.

FIG. 6 is a diagrammatic illustration of an STM utilizing a movable vaneand an optical sensing system for detecting the velocity and magnitudeof the vane movement.

FIG. 7A is a diagrammatic illustration showing a modified STM having anoptical light pipe and in which an optical sensor is positioned insidean optical post.

FIG. 7B is a view of the modified STM shown in FIG. 7A with the sensorand transmission modules in a detached state.

FIG. 8A is a diagrammatic illustration showing another modified STMwithout an optical light pipe.

FIG. 8B is a view of the modified STM shown in FIG. 8A with the sensorand transmission modules in a detached state.

FIG. 8C is a diagrammatic perspective view of the modified STM shown inFIGS. 8A and 8B.

FIG. 9 is a sectional view illustration of an STM utilizing a movablevane and an acoustic sensing system.

FIG. 10 is a sectional view illustration of a modified STM utilizing anacoustic sensing system without any moving parts.

FIG. 11 is another example of a system for an IDMS.

FIG. 12 is an example of the configuration of an IDMS server.

FIG. 13 is an example of a methodology for configuring a Sensor Unit.

FIG. 14 is another example of a methodology 1400 for configuring aSensor Unit.

FIG. 15 is an example of a methodology for sending sensor data.

FIG. 16 is an example of a methodology for receiving sensor data.

FIG. 17 is an example of a methodology for receiving and displayingprocessed data.

FIG. 18 is an example of a methodology for defining a service.

While the invention is susceptible to various modifications andalternative forms, specific embodiments have been shown by way ofexample in the drawings and will be described in detail herein. Itshould be understood, however, that the invention is not intended to belimited to the particular forms disclosed. Rather, the invention isintended to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the invention as defined by theappended claims.

DETAILED DESCRIPTION OF THE INVENTION

Although the invention will be described in connection with certainpreferred embodiments, it will be understood that the invention is notlimited to those particular embodiments. On the contrary, the inventionis intended to cover all alternatives, modifications, and equivalentarrangements as may be included within the spirit and scope of theinvention as defined by the appended claims.

Most medical diagnostic or monitoring instruments typically include (1)a front-end sensing module (with a specific sensor and related signalprocessing circuitry), (2) an electronic system module (composed of akeypad, display, microprocessor, etc.). (3) a software module (foranalysis of measurements and other parameters, etc.) and (4) acommunication module to connect all the modules to each other and toconvey the data or the results of the analysis—often manually—to thephysician, the insurance company, etc.

One aspect of the present invention is directed to reducing a medicalinstrument, related to personal healthcare monitoring, to its majormodules. The front/patient-end module includes a sensor system (for thespecific monitoring parameter) that is simple, inexpensive, affordable,and easy to use and carry. The raw data, whether digital or analog, isamplified, conditioned, and converted to a standard signal, whichincludes a specific device identifier. This data is communicatedwirelessly or via a wired connection to a mobile communication devicesuch as a smartphone, a PC, a tablet, a PDA, etc. via an applicationdownloaded to the mobile communication device. The data is generally inthe same form as a typical voice/acoustic or text data signal that iscommunicated to a mobile communication device, so that the signal isuniversally applicable to all mobile communication devices (which areprimarily designed to transmit and receive voice/acoustic or text data).

The application directs the incoming signal to a specific website ornetwork address that recognizes the device and automatically analyzesthe signal. The results are transmitted from the server to variouslocations in relevant formats—to the patient, the clinic/hospital,electronic medical record (“EMR”) repository, electronic health record(“EHR”) repository, the physician, the insurance company, etc. With the“whole” system approach illustrated by features of the presentinvention, including the Internet-based disease monitoring systemdescribed below, the cost, bulk, and complexity of the system isconsolidated and redistributed away from the patient-end toward theserver and infrastructure end, where it amounts to a small increment andis more readily tolerated and afforded.

Ongoing relative costs are also redistributed in the form of appropriatesubscriptions. For example, simple text/internet link subscriptions areavailable for the patient, and data-access subscriptions are availableto the clinic, physician, insurance company, etc. The system also allowsa direct video link between the patient and the physician, for example,via cell-phone cameras or tablet or PC webcams for a more intimate,personalized, and clinically useful assessment of the patient'scondition.

FIG. 1 illustrates a system 100 in which a patient 102 uses a spirometer104 to monitor the patient's respiratory condition. The patient breathesinto the spirometer 104, both inhaling and exhaling, and the spirometerautomatically detects the displacement and rate (volume and velocity) ofair movement through a flow chamber in response to the patient'sbreathing. The spirometer 104 also produces electrical output signalsrepresenting the detected parameters (e.g., volume and velocity), andbroadcasts those output signals into a near-field region surrounding thespirometer. In the illustrative system 100, those near-field signals aredetected and received by the patient's smartphone 106, which includes anapplication (“APP”) for detecting such signals and transmitting them topredetermined destinations via a network 108 such as the Internet.

In FIG. 1 , the potential destinations illustrated are a remote server110, a health insurance company computer 112, a clinic 114, and/or aphysician smartphone 116. The specific destinations to which results andreports are forwarded are selected by the caregiver (physician,clinic/hospital) and saved in the central cloud-based server 110 wherecomputations are conducted, such as automatic processing andauthenticated closed-loop for credibility where it may not be subject topatient's accidental or willful changes. Alternatively, the patient'ssmartphone 106 may be used to preselect, via settings made in thepatient's smartphone 106, the specific destinations to which signalsreceived from the spirometer 104 are to be forwarded. The settings areselected via a display generated by the APP in a settings window of thepatient's smartphone 106.

The illustrative system 100 includes three software modules: a front-endsensor-transmitter module (“STM”) 120A, a mobile communication anddisplay module (“MCDM”) 120B, and an Internet-based server for dataprocessing and distribution module (“DPDM”) 120C. The STM 120A includesa precise sensor to generate raw signal data and circuitry and/orsoftware for signal conditioning. The raw signal data is optionallyencrypted (e.g., using SSL) and transmitted wirelessly (e.g., usingBluetooth or ZigBee at 2.4 GHz). The STM 120A transmits a device ID withencrypted patient-specific header/demographics and raw sensor data indigital/text form to the patient's smartphone 106.

One example of the STM 120A is a pocket electronic spirometer (“PES”)for measuring and monitoring pulmonary function, as described in U.S.Pat. No. 5,816,246. As described in more detail below, the sensor may bea simple, low cost, but highly precise (1000-1500 dpi or even greaterresolution) device, such as a light-emitting diode (“LED”) device orlaser-based device. In another example, the sensor is the same as thatused in a Bluetooth mouse.

The MCDM 120B includes two specific mobile/cell-phone APPs—one for thepatient's smartphone 106 and another for the physician's smartphone 116.The APPs are custom written in mobile java or other format for thesmartphone 116 to connect to the remote server 110 and to transmit theraw data to the remote server 110 for analysis, distribution, and/orstorage.

The DPDM 120C includes the remote server 110, server software modules,sensor-specific computational modules, reporting modules, databasearchiving (basic web-page, spirometry data, or full interactive web-sysfor multiple sensor systems) and PC software module for insurancecompanies 112, clinics and medical facilities 114, pharmacies 116, etc.

A physician normally prescribes the STM 120A to the patient afterinitial testing at a clinic or hospital and having determined a specificdiagnosis and established norms for the patient. The STM 120A isinitiated at the physician's office, with basic patient information andis assigned a record number as a basic identifier for the patient andhis/her diagnosis/condition, type of test, etc. The physician also setscertain alarms specific to the patient's condition to serve as remindersor warning alerts that immediate physician attention is required.

Desired parameters are calculated and formatted on the remote server 110in various formats for the patient, the clinic record, the physician,EMR/EHR database, medical insurance company, etc. The parameters arefurther optionally formatted in any other desired format previouslyidentified and saved on the remote server 110. The remote server 110automatically directs data in appropriate formats to appropriate nodesof the system 100. For example, the patient receives the most simplifiedversion appropriate for self-monitoring and management of the disease orcondition with any applicable medical advice based on the results.Detailed data is transmitted to the clinic, appropriate formatted datais transmitted to the EMR/EHR database, and financial and reimbursementrelated data is transmitted to the insurance company in an appropriatebilling format. If the patient parameters are in the warning alarmrange, appropriate personnel are alerted and alert messages areautomatically transmitted to the clinic/hospital 114, the physician'ssmartphone 116, and the patient's smartphone 106.

Referring to FIG. 2 , the system 100 is further interconnected in ahub-and-spoke configuration such that each component and/or device isdirectly and/or indirectly communicatively coupled with one or more ofthe other components and/or devices. For example, the patient'ssmartphone 106 (e.g., a cellular phone) communicates directly with thespirometer 104 and the Internet 108, and is optionally also connected toan eHealth server 110. Similarly, a patient tablet 111 communicatesdirectly with the spirometer 104 and is optionally connected to theeHealth server 110 and/or computers of medical insurance companies 112.The patient tablet 112 may provide the patient additional options and/ora more user-friendly interface than the patient's smartphone 106.

Referring to FIG. 3 , an illustrative STM 130 includes severalsub-modules and/or components, including a flow-chamber mouthpiece 132,a flow-chamber housing 134, a spring-loaded vane 136, a digital signalprocessor (“DSP”) 138 (which is positioned at a convenient point on acircuit board), an optical or acoustic sensor system 140, and atransmitter system 142. In general, a patient blows air into theflow-chamber mouthpiece 132, forcing air into the flow-chamber housing134. The forced air causes movement of the spring-loaded vane 136, themovement being sensed and tracked by the sensor system 140. The sensorsystem 140 produces signals that are optionally conditioned and/ordigitized prior to being transmitted by the transmitter system 142. Theprocessor 138 optionally performs required tasks associated, forexample, with the conditioning, digitizing, and/or transmission of thesignals. The STM may optionally have a secure feature to ensure only thepatient-owner may be able to use the device, such as in combination withthe patient's own paired smartphone, to automatically transmit testdata.

The sensor system 140 includes one or more patient sensors, signalconditioning circuitry, and/or digitization circuitry. The sensor system140 senses, for example, a patient condition measured by a spirometer,an OEM blood glucose meter, or a cholesterol monitor. The sensor system140 further senses, by way of a further example, a patient conditionassociated with blood oxygen saturation (“SpO₂”), nitric oxide levels,and other conditions. The flow chamber module may be replaced byspecific modules for other disease conditions to connect with thetransmitter module to complete the STM patient device.

The transmitter system 142 includes circuitry and/or components, forexample, for signal amplification and/or encryption. The transmittersystem 142 further includes circuitry and/or components for Bluetooth,Wi-Fi, and/or ZigBee transmissions. As such, the transmitter system 142can transmit a full range of digital and/or analog data received from avariety of sensors.

Referring to FIG. 4 , a method of monitoring a patient conditionincludes step 140 in which a patient uses the STM at a physician'soffice to initiate a telemedicine system. Prior to initiating thetelemedicine system, the physician tests the patient's respiratoryfunctions to establish and record the patient's baseline spirometryvalues. To do so, the physician may use a clinic-based IDMS-spirometrymodule with a disposable breath flow chamber or the patient's ownIDMS-spirometry module and flow chamber.

Then the STM, which has a unique serial number embedded foridentification, is initialized at the physician's office. For example,the initiating includes setting a patient ID, setting one or morealarms, and setting the specific destinations where the results and/orreports are to be automatically transmitted. The STM is connected with amaster clinic-based system associated with the physician and key patientdemographics and health information is inputted from the clinic-basedsystem. The information is inputted, for example, by bar code scanningor via a user interface. After relevant data is downloaded, the data isencrypted and embedded in the patient's STM. The physician updates theinformation as and when needed. Basic patient demographics and healthinformation embedded in the STM typically includes one or more of thefollowing information: (a) a patient identification number; (b) a name,address, and telephone number for the patient; (c) patient gender andage; ((1) patient diagnosis; (e) physician name and identificationnumber; (f) patient's insurance carrier and number; (g) patient'spreferred pharmacy and contact information for prescriptions; and/or (h)smoking habits.

At step 142 the patient uses the STM at specified times, e.g., whenneeded (depending on the patient's condition) or when prompted. Forexample, the physician instructs the patient to use the STM everymorning to monitor the patient's health condition.

At step 144, the sensor system of the STM produces a signal indicativeof a patient condition and, in response, the sensor system and/or thetransmitter system of the STM condition, encrypt, convert to voiceand/or data, and transmit the signal wirelessly or by wire. At step 146,a patient's mobile device (e.g., a smartphone or cellular phone)receives the signal and logs onto a dedicated website server. The serverauthenticates, at step 148, the patient and/or the mobile device, andreceives, processes, and transmits results of the patient condition tothe physician and patient mobile devices, and to all other identifieddestinations.

At step 150 the results are transmitted in the form of data to a clinicwhere the patient is registered, to other medical services forinterpretation, to the patient's medical insurance company, and/or to anEHR medical records database. At step 152 the physician is alerted, forexample, by a smartphone and/or a PC if test data reaches set criticallimits. The physician connects with the patient via phone and/or videolink at step 154 to discuss the results of the monitored condition andadvice.

Referring to FIG. 5 , a mobile APP is directed to monitoring a patientcondition and includes, at step 160, initiating a medical test. Themobile device (e.g., cellular phone) is awakened in response toreceiving an incoming wireless signal (e.g., received via Bluetooth orZigBee) from the STM upon the patient conducting the medical test. Datarepresentative of the medical test is received by the mobile device.

At step 162 the patient mobile device connects to an IDMS web-basedserver via an incoming data port. At step 164 the mobile device receivesa confirmation signal from the IDMS server. At step 166 the mobiledevice forwards the data to the IDMS server. The data is optionallyforwarded as encrypted raw data.

At step 168 the mobile device is awakened by a signal from the IDMSserver that incoming results are being or have been sent by the IDMSserver. For example, the mobile device receives a confirmation textmessage from the IDMS server that the results are completed.

At step 170 the mobile device alerts the patient that the results havebeen received. For example, the mobile device generates an audio and/orvisual alert in the form of a text message to alert the patient.

At step 172 the mobile device displays the results in a default testdata format or in a format specified by a physician. The displaying canbe, for example, as simple as opening a text message to view theresults.

At step 174 the mobile device facilitates a communication connectionbetween the patient and the caregiver (e.g., the patient's physician,clinic, or hospital). For example, upon selection of an icon on a screenof a smartphone or a button on a cell phone keypad, the patient connectswith the caregiver and talks or leaves a voicemail or text message. If avoicemail or text message is left with the caregiver, an incoming callor message from the caregiver is subsequently signaled on the mobiledevice, allowing the patient to receive and respond after authenticatingby the patient. Patient log-in information may be enabled or disabled,depending on selected security preferences. Optionally, a unidirectionalor bi-directional video communication is initiated with the caregiver.The video communication may include turning on respective cameras onmobile devices for the patient and/or the caregiver.

At step 176 the mobile device provides options for patient selection ofother environmental data and/or health information. For example, themobile device allows selection of icons for pertinent environmental dataand/or other important health information and/or health tips. Forexample, based on the location of the mobile device (e.g., using GPScoordinates), the options may include information related to ozonelevel, pollution index, smog level, and heat index acquired from publicweb sites and/or the server 110.

At steps 178 and 180 the mobile device captures/receives and displaysthe selected environmental data and/or health information. Thedisplaying of the data/information is presented upon demand and/or withtest results.

By way of background, spirometry is measurement of a patient'srespiratory condition and capacities. As such, a typical spirometer isan instrument used to measure the inspiratory and expiratory performanceof the patient's lungs. Most prior spirometers utilize pressuretransducer-based sensors called pneumotachometers to measure pressurevariations in a tube of a fixed volume as the breath flows through thetube and to calculate several flow- and volume-based respiratoryparameters from the measured pressure variations. Another commonprevious technique utilizes a turbine inside a breath flow tube. Theflow of breath turns the turbine, and the rotation of the turbine's finsis measured by corresponding interruption of an optical beam. Theseprior techniques require the breath to flow directly over themeasurement mechanism, further requiring the use of disposable filtersand disposable pressure transducers and/or interfaces to preventbacterial contamination and clogging of the system due to warm and moistbreath of the same or multiple patients. These additional elementsaffect accuracy of the measurements, requiring constant corrections inthe software, and add additional complexity, bulk, and costs to priorspirometer systems. Thus, these systems also require frequentcalibrations.

Improved spirometers described below eliminate all the moving parts onthe measurement side, other than the vane, making the system simpler,more rugged, and more economical to produce and to own. Theseimprovements allow complete elimination of all moving parts (gears,encoder, etc.) from a main housing. For improved optical configurationsdescribed below, the only remaining moving part is the vane inside theflow chamber. For an improved acoustic configuration described below,even the vane is eliminated, leaving no moving parts in the entiresystem.

Utilizing precision high tech, but extremely low cost, optical sensingcomponents, as used in an optical/laser mouse for cursor control on acomputer, the system further improves accuracy through higherresolution. The system functions in much the same way as an opticallaser mouse operates, thus improving resolution, accuracy, responsetime, and reliability, and producing digital signal. This furthersimplifies the system by eliminating the need for analog-to-digitalconversion circuitry and also reducing the potential errors and cost.

Referring to FIG. 6 , and by way of a specific example, an STM is in theform of a spirometer 200 with a flow-chamber 202. The flow-chamber 202includes an encased spring-loaded vane 206 mounted for pivotingbidirectional movement about an axis 215 in the central portion of theflow chamber, defined by a stationary shaft or stub, in response to thepatient's breathing in and out through the flow chamber. According toone example, the flow-chamber 202 is a circular washable and/ordisposable plastic flow-chamber housing having inlet and outlet openingsto accommodate a patient's breathing through the chamber.

The spirometer 200 includes a light source 208 coupled to a firstoptical light pipe 210 that extends through the spring-loaded vane 206so as to emit light from the free end of the vane 206 onto the wall ofthe flow chamber 202. Light reflected by the wall of the flow chamber ispicked up by the end of a second optical light pipe 214 that extendsthrough the vane 206, parallel to the first light pipe 210, to an imagesensor 212 such as a charge-coupled device (“CCD”) image sensor or acomplementary metal-oxide-semiconductor (“CMOS”) image sensor. The imagesensor 212 tracks bi-directional displacement, caused by breathexpiration and/or inspiration, of the spring-loaded vane 206 inside theflow-chamber 202. The image sensor 208 transmits the image to a DSP(such as DSP 138 illustrated in FIG. 3 ) for analysis.

An initial cracking-point from a resting position of the spring-loadedvane 206, in either direction, sets a system calibration referencepoint. According to one example, a spirometer has been constructedutilizing PC and computer mouse components and a custom softwareapplication in Visual Basic, and a full breath displacement has beencaptured with a 10 millisecond sampling rate, with captured data beingimported into an Excel spreadsheet in which a flow-volume loop and avolume-time graph were developed.

Changes between one image frame and a next image frame are processed bythe image processing part of the DSP 138 and translated into movement ontwo axes. For example, the ADNS-2610 optical mouse sensor manufacturedby Agilent Technologies processes 1512 image frames per second, witheach image frame being a rectangular array of 18×18 pixels and eachpixel sensing 64 different levels of gray. The DSP 138 detects patternsin the images and recognizes how those patterns have moved since theprevious image. Based on the change in patterns, the DSP 138 determineshow far the vane 206 has moved and transmits the correspondingcoordinates to the microprocessor 232. This occurs hundreds of timeseach second, making the measurement very smooth and able to detect anyaberration in the breathing pattern to track the breath precisely.

Instead of using a LED-based emitter 212, an IR laser diode isbeneficial because it uses a laser beam with which the measurement iseven more precise, giving better response times and tracking. Asingle-chip optical mouse sensor like STMicroelectronics VT 5365 isoptionally used for wireless and Bluetooth applications. Thissingle-chip economical solution provides an internal microprocessor andminimal external circuitry, low power requirement, long battery life,operation with up to 10,000 frames per second, and tracking at up to 40inches per second.

Another even more effective optical sensor system is a compact (6.8 mmsquare, 3.86 mm high) Philips PLN2033 “Twin-Eye” laser sensor based onLaser Doppler technology. It is a high-precision, ultra-fast, low-power,small-sized, single-component, laser-based tracking device for use ininput and navigation devices like professional PC mice, gaming and CADapplications, and graphical workstations. The PLN2033 “Twin-Eye” lasersensor offers accurate performance over a wide range of speeds andaccelerations on virtually all light scattering surfaces covering thedemands for applications such as gaming and office applications. Itmeasures changes in position by detection of the scattered coherentlaser light that is reflected by a surface, and mathematically byon-chip logic and software, determining the direction and magnitude ofthe movement up to 3.8 meters per second for each axis (150 inches persecond). It is capable of measuring extremely accurately with are-programmable resolution ranging from 100 CPI to 6400 CPI. Theresolution can be re-programmed with an accuracy of 1 CPI.

Referring to FIGS. 7A and 7B, modified embodiments of the spirometer 200illustrated in FIG. 6 utilize a combination light emitter/image receiver216 such as the Philips “Twin-Eye Laser” sensor (PLN2023) or Philips“Laser Doppler” sensor. This combination device 216 permits the use of asingle light pipe 210 that both transmits light from the device 216 tothe wall of the free end of the vane 206, and picks up light reflectedfrom the wall of the flow chamber 202 and transmits that reflected lightback to the device 216. In FIG. 7A, the device 261 and the adjacent endportion of the light pipe 210 are aligned with the axis 215. In FIG. 7B,the device 216 and the light pipe 210 are aligned with an axis 217 thatextends diagonally through the vane 206 so as to emit light from the topedge of the vane 206 onto the upper wall of the flow chamber 202. Lightreflected back from the upper wall of the flow chamber light is pickedup by the light pipe 217 and transmitted back to the device 216.According to one example, the light pipe 217 and the device 216 areoriented at an angle of about 15-30 degrees from a vertical postreceiver axis 215.

Referring to FIGS. 8A-8C, another modified embodiment of the spirometer200 illustrated in FIG. 6 utilizes direct pick-up of displacement of thespring-loaded vane 206 without the use of any light pipes. In thisembodiment, the combination light emitter/image receiver 216 is mountedon a base 204 adjacent the lower surface of a disc 218 formed as anintegral part of the vane 206 so that the disc moves with the vane, thusproviding relative movement between the disc and the stationary device216.

Regardless of the particular optical configuration, thousands ofsuccessive pictures of the surface area immediately in front of theimage sensor 208 may be captured, with or without a respective opticallight pipe conduit. Based on the thousands of images that the imagesensor 208 transmits to the DSP 138 for analysis, the DSP 138 detectsboth patterns and movement of the vane 206. As such, the DSP 138determines if the vane 206 has moved, and if so, determines thedisplacement, speed, and direction of the movement. In turn, the speedand movement of the vane 206 in the fixed space within the flow-chamber202, against the inspiratory and expiratory breath, translate to volumeand flow measurements of spirometry.

The acoustic implementations are preferably integrated into the fullsystem in the same way as the optical implementations described above(i.e., using acoustic sensors instead of optical sensors). Thus, theywould also include the sensor and the transmission modules andwirelessly communicate the raw data via cellular phone to thecloud/web-based server for analysis and distribution to all the nodesidentified earlier. Optionally, both the optical and the acousticimplementations can have a microprocessor in the main housing (asdescribed here) that may send the results to the patient cellular phoneand from there still be able to send them to the web-based server toutilize the central monitoring, distribution, and record keepingdescribed earlier.

Referring to FIG. 9 , an acoustic implementation includes a pocketspirometer 220 with a mouthpiece 222 into which a patient blows a breathof air A to drive a vane 224 in a flow chamber 226. The breath of aircreates pressure that causes movement of the vane 224, displacing thevane 224 from an initial position. The movement of the vane 224 issensed by an acoustic sensor system having an acoustic emitter 234 and amicrophone 236. The acoustic sensor system utilizes a vane surface toreflect emitted sound (similar to a Doppler effect) as the vane 224 isdisplaced by the flow of breath air A. The position of the vane 224 isdetermined and provides a basis for calculating volume and flow ratewithin the flow chamber 226.

The acoustic sensor system is positioned external to the flow chamber226 and within a main housing of the spirometer 220 in which otherelectronic components are mounted. The acoustic sensor system is coupledto the flow chamber 226 via a thin-walled window to maintain a completebacterial-free separation between the patient's breath and the acousticsensor system. The flow chamber 226 is optionally detached from the mainhousing containing electronic components and rinsed for re-use.

The microprocessor 232 provides results to a display of a device, suchas an LCD display of a patient mobile device, and stores the resultsinto an associated memory of the device. Upon storing the results to thedevice memory, the results can optionally be erased from the spirometermemory 230. Optionally, the results are stored on other memory devices,including memory cards and/or personal computers.

At the completion of a test, the microprocessor 232 further determines ahighest value reached on an expiratory flow curve and displays thatvalue as a Peak Expiratory Flow Rate (“PEFR”). Based on a plot of aflow-time curve, a Forced Expiratory Volume in one second (“FEV1) can beeasily calculated. Other parameters such as Forced Vital Capacity(“FVC”), Mid-Expiratory Flow Rate, (“FEF 25-75”), Forced InspiratoryFlow Rate (“FIVC”) at 50% (“FIF 50”), and other parameters are similarlymeasured from the stored data.

Referring to FIG. 10 , another acoustic implementation eliminates thevane 224 such that the spirometer 220 does not require any moving parts.In this streamlined flow chamber configuration, one or more highlysensitive microphones 250 or 252 are positioned externally across athin-walled window 253 in the flow chamber 226 to maintain abacterial-free separation. The inside configuration of the flow chamberincludes a ridge 254 in the air flow path that enhances the sound ofbreath blowing over it.

The microphones 250 or 252 are placed closest to the ridge 254 tomaximize the sound quality, which is further enhanced by a conicalconfiguration leading to the ridge. The microphones capture an acousticsignal generated by the patient's breath as it flows against thisgeometrically optimized internal configuration of the flow chamber.

An acoustic pattern generated by the flowing breath correlates to theflow and volume inside the fixed space of the flow chamber for bothexpiration and inspiration. The simplified flow chamber is detachableand optionally a disposable or a reusable (e.g., rinse-able) unit. Twomicrophones, instead of a single microphone, are helpful in determiningthe direction of flow corresponding to expiration and inspiration.

With respect to FIG. 11 , another example of a configuration for IDMS isshown. System 1100 may consist of a network 1102, such as the Internet,LTE, etc., which communicatively couples server 1104, third-party server1106, personal computer 1108, smartphone 1110, and sensor unit 1112.Though only individual examples are shown of the components comprisingsystem 1100, it may contain multiple instances of such components (e.g.,several servers, hundreds of sensor units). Sensor unit 1112 may becomposed of a simple sensor component communicatively coupled to anetwork or additionally a smartphone or PC also communicatively coupledto a simple sensor component. Sensor unit 1112 may also be partially orfully integrated with prescription delivery devices (e.g., patientmedication use (such as inhaler puffs) can be measured). Server 1104 andsensor unit 1112 may also apply date/time stamps to data recorded orsent/received in order to facilitate services provided by servicescomponent 1208 described below.

As shown in FIG. 12 , an example of the configuration of an IDMS serveris shown. System 1200, which may be used for server 1104, may beconfigured to have a database component 1202, an analytic component1204, a network component 1206, and a services component 1208. Databasecomponent 1202 may be used to store or retrieve data useful to an IDMS,such as raw data received from sensor unit 1112, analytical results fromanalytic component 1204, messages sent to or from network component1206, and processed data or other records handled by services component1208. Analytic component 1204 may be used to handle the analysis of rawdata obtained from sensor unit 1112 or may further process analyzed databased on instructions from services component 1208. Network component1206 may be responsible for handling communications with other systemsor devices, such as those shown by system 1100. In addition, networkcomponent 1206 may also handle the generation of messages based oninformation received from database component 1202, analytic component1204, or services component 1208. Services component 1208 may be used toimplement various services provided by the IDMS to patients, doctors,insurance providers, emergency dispatch operators, etc.

With respect to FIG. 13 , an example of a methodology 1300 forconfiguring a sensor unit is shown. At step 1302, the sensor unit may beinstructed to send a sensor unit ID, such as via the Internet. Thesending of the sensor unit ID may occur when sensor unit 1112 isinitialized, reset, or upon being power on. In some embodiments, thesensor unit ID may be assigned to sensor unit 1112 by server 1104 aspart of an initialization process (e.g., upon device detection by server1104). In some embodiments, the sensor unit ID may be programmedpermanently into sensor unit 1112, such as a unique identifier stored infirmware. At step 1304, sensor unit 1112 may receive a patient ID, whichsensor unit 1112 may use to associate with sensor data obtained fromsensor unit 1112. At step 1306, sensor unit 1112 may receive patientsettings, which may contain information such as patient data,configuration settings for sensor unit 1112, etc. The patient settings(or patient ID) may also include a cryptographic key or instructionsrelating to the exchange of a cryptographic key, which sensor unit 1112may use for encrypting sensor data or other information. At step 1308,the sensor unit 1112 may perform a self-test or a user-operated test ofsensor unit 512, which may include generating information useful tocalibrating sensor unit 1112. At step 1310, sensor unit 1112 may sendthe data relating to a self-test or user-operated test. In someembodiments, such data may also be encrypted using information obtainedfrom the patient ID or patient settings. At step 1312, sensor unit 512may receive calibration settings, such as instructions to modify sensordata or adjusting the operation of sensor unit 512. In some embodiments,steps 1308-1312 may performed more than once, such as where calibrationrequires sending further test data to determine if a calibration isvalid. At step 1314, sensor unit 512 may receive instructions or anotice that it is ready to take measurements.

With respect to FIG. 14 , another example of a methodology 1400 forconfiguring a sensor unit 1112 is shown. At step 1402, a sensor unit IDmay be received, such as via the Internet. The sensor unit ID may beunique to a particular sensor unit 1112. At step 1404, sensor unit 1112may retrieve or generate a patient ID that may be used to associatesensor data with a patient. At step 1406, patient settings, which maycontain information such as patient data, configuration settings forsensor unit 1112, etc., may be generated or received. In someembodiments, patient settings may depend on sensor unit ID, patient ID,or information provided by services component 1208. The patient settings(or patient ID) may also include a cryptographic key or instructions forexchanging a cryptographic key, which sensor unit 1112 may use forencrypting sensor data or other information. At step 1408, the patientID or patient settings may be sent, such as to sensor unit 1112. At step1410, data relating to a self-test or user-operated test for sensor unit1112 may be received. In some embodiments, such data may also beencrypted using information obtained from the patient ID or patientsettings. At step 1412, calibration settings may be generated orretrieved, such as instructions to modify sensor data or adjusting theoperation of sensor unit 512. In some embodiments, steps 1408-1412 mayperform more than once, such as where calibration requires receivingfurther test data to determine if a calibration is valid. Calibrationsettings generated, retrieved, or sent may also include updates to thesoftware of sensor unit 1112 (e.g., a new smartphone application, newfirmware for a simple wireless sensor unit). At step 1414, instructionsor a notice may be sent indicating that sensor unit 1112 is ready totake measurements.

With respect to FIG. 15 , a methodology 1500 is shown for sending sensordata. At step 1502, sensor data is received, such as from a sensorcomponent on sensor unit 1112. At step 1504, the sensor data may beencrypted, such as via a patient ID or patient settings stored on sensorunit 1112. At step 1506, the encrypted sensor data may be sent, such asfrom sensor unit 1112 to server 1104 via the Internet. At step 1508, amessage may be received confirming acceptance or rejection of theencrypted sensor data. A message indicating rejection data may include anotice that the data was rejected, information describing why theinformation was rejected, or instructions (such as new settings or anindication to perform calibration) for sensor unit 1112. For example,the message may state that the encryption of the sensor data wasincorrect and may also instruct that a new encryption key must beobtained. As another example, the message may provide informationindicating that sensor unit 1112 was not operated properly. For example,analysis of the received sensor data on server 1104 may show that theuser took an inappropriate action (e.g., too rapid of an exhale) forproper measurement and server 1104 may send an instruction to sensorunit 1112 that the user needs to exhale more slowly into a sensorcomponent). A message indicating confirmation of data may include anotice that the data was accepted, information relating to why the datawas accepted, or additional instructions for sensor unit 1112.

With respect to FIG. 16 , an example of methodology 1600 for receivingsensor data is shown. At step 1612, encrypted sensor data may bereceived. For example, server 1104 may receive encrypted data via theInternet. At step 1604, the encrypted sensor data may be authenticatedor decrypted, such as by server 1104. As part of the authenticationprocess, the relationship between the encrypted sensor data and a sensorunit ID, a patient ID, or other identifying information may bedetermined. At step 1606 the decrypted sensor data may undergo analysis,such as by analytic component 1204. For example, the sensor data mayonly provide metrics over time of airflow, which is then used to form agraph of airflow versus time. The sensor data may also be furtheranalyzed, such as to determine if the sensor data is within certainthresholds. At step 1608, the analyzed sensor data may be furtherprocessed, such as from instructions from services component 1208. Forexample, the sensor data and analysis may be processed to form a patientrecord that further includes patient information, insurance information,legal or other informational requirements, etc. At step 1610, theprocessed data may then be sent or stored, such as to a smartphone fordisplay of a graph or to database component 1202 for storage. If theprocessed data is sent, encryption may be applied to the processed dataas described with respect to the sensor data.

With respect to FIG. 17 , a methodology 1700 is shown for receiving anddisplaying processed data. At step 1702, processed data is received,which if encrypted may be decrypted as described with respect to thesensor data. At step 1704, processed data may be displayed, such as on asmartphone that is communicatively coupled with a sensor unit.

In some embodiments, encryption of sensor data or processed data mayfurther include compression of such data. Sensor unit 1112 may becommunicatively coupled with a variety of sensor components, such asthose that measure or perform pulmonary function testing (e.g.,spirometry), EKG, cholesterol, blood glucose, pulse oximetry (bloodoxygen saturation (SpO₂). Sensor unit 1112 may be able to measure highresolution digitized raw data via a sensor component, then conditionsuch data to comply with patient privacy requirements (e.g., HIPAA) aspart of the encryption process. In further embodiments, encryptingsensor data or processed data may include further formatting the datafor a particular message medium. For example, if Internet service is notavailable but instant messaging is available, sensor unit 1112 ornetwork component 1206 may send or receive encrypted messages in theform of encrypted text data sent by instant message. In someembodiments, sensor unit 1112 or network component 1206 may restrict thetypes of sensor data or processed data that may be sent via a particularmessage medium. For example, network component 1206 in response toencrypted sensor data sent by instant message may not send encryptedprocessed data in return, but only may send confirmation as describedabove.

Services component 1208 may be used to handle a variety of services,which may be arranged by clients, sensor unit types, providers,patients, etc., for handling sensor data from sensor units (e.g., sensorunit 1112) and related activities. These services may be definedaccording to one or more of the following functions: grouping;monitoring/compliance; sharing/aggregation; modeling; billing;scheduling; privacy; third party systems; and referral.

For example, a service may be defined according to grouping functions,wherein the members of the service are defined by one or more sensorIDs, one or more patient IDs, or information related to a patient,provider, insurer, patient's medication, a set of services hosted byservices component 1208, etc.

With respect to monitoring/compliance functions, a service may indicatevarious tasks that must be periodically performed. For example, aservice may have access to patient data containing prescriptioninformation for a patient. In such embodiments, server 1104 may use suchprescription information to send messages to sensor unit 1112, personalcomputer 1108, or smartphone 1110 containing reminders to take amedication or that a medication has been prepared at a pharmacy and isready for pickup. In further embodiments, server 1104 may use suchprescription information to send messages to sensor unit 1112, personalcomputer 1108, or smartphone 1110 to trigger a visual or auditoryreminder on a prescription appliance (e.g., a flashing LED on aprescription box that is coupled by Bluetooth to sensor unit 1112) or onsensor unit 1112, personal computer 1108, or smartphone 1110. As anotherexample, rules may be set for how often or when sensor data must bereceived according to sensor unit ID or patient ID associated with aservice. For example, if sensor data is not received for a period oftime (e.g., 7 days), server 1104 may send messages to sensor unit 1112to display a message, sound an alarm, etc. that reminds patient to usesensor unit 1112. In addition, server 1104 may also send a message to apatient care provider or other person associated with the patientindicating that sensor data has not been received. In some embodiments,a service may also contain instructions that environmental data bemonitored and used to send notifications to sensor unit 1112, personalcomputer 1108, or smartphone 1110. For example, a service may requirethat measurements of allergens (e.g., pollen, weeds, etc.), pollution,smog, ozone, heat-index, etc. be monitored based on location-datareceived from sensor unit 1112 (such as via GPS tracking). Suchmeasurements may be sent periodically to sensor unit 1112, personalcomputer 1108, or smartphone 1110 by server 1104. In some embodiments,server 1104 may only send such measurements or information relating tosuch measurements (e.g., instructions to sound an alarm) when suchenvironmental data indicates that an unsafe condition exists for apatient. For example, a provider may have specified that exposure to acertain level of allergens for patients in a service requires theissuance of a message that results in sensor unit 1112 sounding an alarmand displaying a warning to patients to seek a safe environment. In someembodiments, a service may also include instructions related to sendingmessages regarding preventative measures, such as a periodicnotification to sensor unit 1112, personal computer 1108, or smartphone1110 to record patient's weight, replace disposable components of sensorunit 1112, update a patient diary regarding medication usage oractivity, etc.

A service may also be defined according to sharing/aggregationfunctions, wherein rules may be defined for the sharing and aggregationof sensor data, processed data, or information related to a patient. Forexample, a service may allow anonymous processed data obtained fromsensor data to be shared along with relevant patient medication ortreatment history. For example, if a patient is regularly taking aspecific form of medication or treatment for diabetes, relevant sensordata or processed data may be shared anonymously to allow aggregation ofthat data across multiple services. Such aggregation may be handled byanother service handled by services component 1208. For example,multiple services operated by different providers may be members of aservice that exists to aggregate anonymous patient data they provide andcontains instructions for analytic component 1204 on how to process theaggregated data and who may have access to the results. In someembodiments, a service which performs aggregation may be used to providefeedback to other services. For example, the aggregated sensor data maybe used to indicate strong deviations in analyzed or processed sensordata of a particular patient belonging to a service that shares datawith the aggregation service. In some embodiments, a service may performits own aggregation functions, such as where patients are divided intotwo groups where one group uses a placebo and the other a trialmedication. In such situations, analyzed or processed sensor data may beaggregated and further analyzed/processed to show trends based on thesensor data, such that meaningful distinctions between the two groupsmay be observed (e.g., population trends). As another example, aggregatedata may allow for the calculation of regional or population statistics,the prevalence of disease within the measured population, outbreaks,etc. As further example, if particular treatments are found to beparticular effective against an outbreak based on the aggregate data,such treatments may be shared with according to the rules of a serviceto help limit the scale of an outbreak.

In some embodiments, services may perform modeling functions based onthe aggregation of data. For example, if a patient's analyzed orprocessed data shows a consistent pattern over a 3 month period, thensubstantially changes, the service may find similar instances of suchsubstantial changes in aggregated data to predict the consequence ofsuch a change. For example, based on the rate of change in a particularmeasurement, the service may predict the future rate of change andpossibly underlying cause (e.g., creatine levels will increase by 10%per day, likely cause is kidney failure). As another example, aggregatedata may also include environmental data related to the location of eachsensor unit providing data. In such situations, predictions may beperformed based on changes in the environmental data for a particularsensor unit. For example, if the aggregate data shows that increasedallergens affects breathing and the environment of a particular sensorunit experiences increased allergens, the service may calculate aprediction of how a patient's breathing may change due to the presenceof such allergens. Such environmental predictions based on aggregatedata may allow patients or providers to understand the cause of a changein analyzed or received sensor data relating to that patient. In someembodiments, such predictions may also be used to further processanalyzed sensor data (e.g., to create a view of analyzed sensor dataindependent of environmental conditions).

In some embodiments, services may perform billing functions. Forexample, a service may define the type of billing to be used inassociation with a patient's use of sensor unit 1112, which may consistof a pay-per-use (e.g., every validated sensor measurement is billed at5 cents), a subscription service (e.g., $30 per month), pre-paidservices, data plans, subsidies, etc. A service may define a variety ofdifferent ways that functions or sets thereof performed by the serviceshould be billed. A service may also determine how functions shouldoperate (e.g., suspension, termination, limited access) if adequatecredit or funds are not available to cover the costs under such billingrules. A service may also automatically prepare requests forreimbursement for functions performed by the service, which may besubmitted electronically (e.g., to an insurer). For example, a servicemay use patient information (e.g., patient analyzed/processed sensordata, patient condition, diagnosis, physician consultation online,insurance data) to automatically prepare requests for reimbursement forfunctions provided by the service on the behalf of the patient. Asanother example, a service that aggregates data from other services andprovides predictive modeling to those other services may also havebilling rules defined and charges based on those rules automaticallyprepared and submitted by the aggregation service. In the generation ofreimbursement requests, billing rules may also utilize date/time stampsrelating to records, such as sensor data, to determine the extent ofreimbursement that should be requested.

In some embodiments, services may perform scheduling functions. Forexample, a service may automate appointment scheduling and reminderswith corresponding instructions, which may be then sent to sensor unit1112, personal computer 1108, or smartphone 1110 and confirmed by apatient using sensor unit 1112, personal computer 1108, or smartphone1110. In some embodiments, the scheduling rules may also facilitatesetting up audio, video, or text connections between sensor unit 1112and another device. For example, a provider may need to speak to apatient about recent analyzed sensor data and requests for a videoconference call. Server 1104 may then send a request to sensor unit1112, personal computer 1108, or smartphone 1110 that patient accept avideo conference call. If patient accepts, then server 1104 mayfacilitate the setting up of that video conference call.

In some embodiments, services may perform privacy functions. Forexample, rules may be defined in the service regarding who may accessparticular data held by the service, what type of data may be sharedwith other services, the extent to which records must be retained (suchas to comply with record retention policies), etc.

In some embodiments, services may perform third party system functions.For example, rules may be defined regarding when and who may accessthird party systems accessible from a service. In some embodiments, aservice may also define rules regarding how information must betranslated, formatted, or otherwise be prepared for an exchange with athird party system. For example, if a service has generated a requestfor reimbursement to a third party system, further rules may definebilling codes, encryption, etc. that must be added to the reimbursementso that it is processed correctly by the third party system.

In some embodiments, services may perform referral functions. Forexample, a service may contain rules for allowing a provider to consultwith an expert regarding information held by the service. For example, ageneral practitioner may observe processed data and wish to contact anexpert on the disease being monitored. Accordingly, the service maycontain a list of approved experts and conditions the processed datamust meet to obtain access to an approved expert. If the servicedetermines that processed data meets such conditions, consultation withan expert may be approved by the service.

With respect to FIG. 18 , a methodology 1800 is shown for defining aservice. At step 1802, an administrator is defined for the service. Forexample, an administrator may be a patient, a provider, a supportorganization for providers, etc. At step 1804, grouping rules for theservice may be defined, which specify the members of the service.Members may be defined based on static or dynamic conditions. Forexample, members of a service may be defined based on patient IDs,sensor unit IDs, patients assigned to a provider, patients using aparticular medication, patients assigned to a research study, all sensorunit IDs or patient IDs located in a specific region (e.g., California).In addition, a service may be defined as a member of another service. Atstep 1806, monitoring/compliance rules of the service may be defined.For example, rules may be set regarding when or how often informationrequired by the service should be received or notices/instructions sentto ensure compliance by members of the service. At step 1808,sharing/aggregation rules may be defined as to how sharing oraggregation of data held by service, such as sensor data received frompatients or analysis thereof. At step 1810, modeling rules may bedefined as to how data held by the service should be used to predictfuture conditions or adjust existing data. At Step 1812, billing rulesmay be defined as to how functions performed by the service should bebilled. At step 1814, scheduling rules may be defined, such asdetermining when appointments should be scheduled or the process forarranging an online consultation. At step 1816, privacy rules may bedefined, such as who may access data held by a service and when. At step1818, third party system rules may be defined. For example, rulesstating what third party systems may access from the service, who mayaccess such third party systems, and the conditions for when access tosuch third party systems may be defined. At step 1820, referral rulesmay be defined for the service. For example, a set of experts may bedefined and conditions set for when an expert may be consulted.

While particular embodiments and applications of the present inventionhave been illustrated and described, it is to be understood that theinvention is not limited to the precise construction and compositionsdisclosed herein and that various modifications, changes, and variationscan be apparent from the foregoing descriptions without departing fromthe spirit and scope of the invention as defined in the appended claims.

What is claimed:
 1. A system comprising a medical device; a transmissionmodule configured for coupling to a sensor for producing input signalsresponsive to a patient condition, the transmission module comprising: atransducer configured for transducing raw input signals from the sensor,the transducer operatively coupled to the sensor and a digital signalprocessor, the transducer comprising an image receiver for capturingimages based on displacement of a vane within a flow chamber of themedical device operatively coupled to the transmission module; thedigital signal processor operatively coupled to at least one processor,the digital signal processor configured for receiving the transduced rawsignal from the transducer and converting the transduced raw signal toraw digital data; the at least one processor operatively coupled to atransmitter, the at least one processor configured for encrypting theraw digital data and converting the raw digital data into a raw datapackage, the raw data package including a sensor unit ID associated withthe sensor; and the transmitter configured for transmitting the raw datapackage to a mobile device for forwarding the raw data package to aserver; and the server configured for: authenticating the raw datapackage based on the sensor unit ID; decrypting the raw data package;extracting the raw digital data from the data package; analyzing the rawdigital data by calculating parameters based on the raw digital data andsensor-specific computations; determining whether the calculatedparameters are within a certain threshold; adding the results of thedetermination of whether the calculated parameters are within thecertain threshold to a user record; and transmitting the results of thedetermination and the calculated parameters in one or more formats toone or more locations.
 2. The system of claim 1, wherein thetransmission module further comprises a light-emitting source.
 3. Thesystem of claim 2, wherein the light-emitting source is a light-emittingdiode or laser diode.
 4. The system of claim 1, wherein the medicaldevice further comprises a disc coupled to the vane configured forpivotal displacement in response to air passing over the vane; and theimage receiver detects changes in a location of the vane when the vaneis pivotally displaced based on movement of the disc.
 5. The system ofclaim 4, wherein the medical device further comprises a conicalconfiguration leading to a ridge.
 6. The system of claim 1, wherein theserver is further configured to: receive location data associated withthe mobile device and environmental data based on the location of themobile device, the environmental data associated with one or more of:measurement of allergens, ozone level, pollution index, smog level, andheat index; and transmit the results of the determination, thecalculated parameters, and environmental data in one or more formats toone or more locations.
 7. The system of claim 1, wherein analyzing theraw digital data by calculating parameters comprises the servercomputing calculated respiratory function parameters based on thetransmitted raw data package and sensor-specific computation.
 8. Thesystem of claim 1, wherein the raw data package transmitted to theremote server is in the same form as cellular voice data signal or textdata signal, or a combination thereof.
 9. The system of claim 1, whereinthe transmission module performs no functions on the raw signals, theraw digital data, or the raw data package, other than: at thetransducer, transducing raw signals; at the digital signal processor,receiving the transduced raw signal from the transducer and convertingthe transduced raw signal to raw digital data; at the at least oneprocessor, encrypting the raw digital data and converting the rawdigital data into the raw data package; and at the transmitter,transmitting the raw data package.
 10. The system of claim 1, whereinthe server performs all functions on the raw signals, the raw digitaldata, and the raw data package, other than: transducing raw signals atthe transducer; receiving the transduced raw signal from the sensor andconverting the transduced raw signal to raw digital data at the digitalsignal processor; encrypting the raw digital data and converting the rawdigital data into the raw data package at the at least one processor;transmitting the raw data package to the mobile device at thetransmitter; and forwarding the raw data package at the mobile device tothe server.
 11. A system comprising a medical device; a transmissionmodule configured for coupling to a sensor for producing input signalsresponsive to a patient condition, the transmission module comprising: atransducer configured for transducing raw input signals from the sensor,the transducer operatively coupled to the sensor and a digital signalprocessor, the transducer comprising an image receiver for capturingimages based on displacement of a vane within a flow chamber of amedical device operatively coupled to the transmission module; thedigital signal processor operatively coupled to at least one processor,the digital signal processor configured for receiving the transduced rawsignal from the transducer and converting the transduced raw signal toraw digital data; the at least one processor operatively coupled to atransmitter, the at least one processor configured for encrypting theraw digital data and converting the raw digital data into a raw datapackage, the raw data package including a sensor unit ID associated withthe sensor; and the transmitter configured for transmitting the raw datapackage to a mobile device for forwarding the raw data package to aserver, the mobile device performing no functions on the raw datapackage other than forwarding the raw data package to the server and theraw data package transmitted to the remote server is in the same form ascellular voice data signal or text data signal, or a combinationthereof; and the server configured for: authenticating the raw datapackage based on the sensor unit ID; decrypting the raw data package;extracting the raw digital data from the data package; analyzing the rawdigital data by calculating parameters based on the raw digital data andsensor-specific computations; determining whether the calculatedparameters are within a certain threshold; adding the results of thedetermination of whether the calculated parameters are within thecertain threshold to a user record; and transmitting the results of thedetermination and the calculated parameters in one or more formats toone or more locations.
 12. The system of claim 11, wherein thetransmission module further comprises a light-emitting source.
 13. Thesystem of claim 12, wherein the light-emitting source is alight-emitting diode or laser diode.
 14. The system of claim 11, whereinthe system further comprises a disc coupled to the vane configured forpivotal displacement in response to air passing over the vane; and theimage receiver detects changes in a location of the vane when the vaneis pivotally displaced based on movement of the disc.
 15. The system ofclaim 11, wherein analyzing the raw digital data by calculatingparameters comprises the server computing calculated respiratoryfunction parameters based on the transmitted raw data package andsensor-specific computation.
 16. The system of claim 11, wherein thetransmission module performs no functions on the raw signals, the rawdigital data, or the raw data package, other than: at the transducer,transducing raw signals; at the digital signal processor, receiving thetransduced raw signal from the transducer and converting the transducedraw signal to raw digital data; at the at least one processor,encrypting the raw digital data and converting the raw digital data intothe raw data package; and at the transmitter, transmitting the raw datapackage.
 17. The system of claim 11, wherein the server performs allfunctions on the raw signals, the raw digital data, and the raw datapackage, other than: transducing raw signals at the transducer;receiving the transduced raw signal from the sensor and converting thetransduced raw signal to raw digital data at the digital signalprocessor; encrypting the raw digital data and converting the rawdigital data into the raw data package at the at least one processor;transmitting the raw data package to the mobile device at thetransmitter; and forwarding the raw data package at the mobile device tothe server.